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Generics/General

Oxycodone V13D19

FDA is dragging its feet over oxycodone generics

Generics/General | Posted 19/04/2013

The US patent for Purdue Pharma’s (Purdue’s) blockbuster painkiller OxyContin (oxycodone) expired on 16 April 2013, but FDA has yet to approve any generic versions. Now, FDA has announced that it will not approve any generics of the original formulation OxyContin.

Australia flag V13C29

Why choose generic medicines initiative launched in Australia

Generics/General | Posted 29/03/2013

The Australian Generic Medicines Industry Association (GMiA) and the Pharmacy Guild of Australia announced on 22 March 2013 the launch of a joint initiative: Why choose generic medicines?

India V13C03

India may move away from compulsory licensing

Generics/General | Posted 15/03/2013

The Indian Government, in a move that goes away from recent decisions, has suggested that the prices of patented pharmaceutical drugs be controlled by linking them to the country’s per capita income rather than by issuing compulsory licences.

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UN urges WTO to keep cheap drug deal for poor countries

Generics/General | Posted 08/03/2013

Two United Nations (UNs) agencies are urging the extension of an exemption for least-developed countries on patent protection to ensure that HIV/AIDS and other lifesaving drugs remain affordable for the poor.

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French Government pushing generics

Generics/General | Posted 11/01/2013

The French are in general mistrusting of generics with many choosing to stay with brand-name drugs. However, with rising healthcare costs and austerity measures hitting healthcare budgets, the French Government has had to introduce measures to increase generic drug use in the country.

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India urged to drop cost-based drug policy

Generics/General | Posted 30/11/2012

Indian industry trade group the Associated Chambers of Commerce and Industry of India (ASSOCHAM) has urged the Indian Government to drop its cost-based price controls on both brand-name and generic drugs and instead introduce a market-based pricing policy.

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Momenta versus Amphastar and the safe harbour provision

Generics/General | Posted 26/10/2012

On 3 August 2012, the US Federal Circuit issued a decision holding that the safe harbour* provision of the Hatch-Waxman Act 35 U.S.C. § 271(e)(1) covers post-approval testing as long as it is ‘reasonably related’ to the submission of information to FDA. The case involved was that of Momenta Pharmaceuticals (Momenta) versus Amphastar Pharmaceuticals (Amphastar) (Federal Circuit No. 2012-1062, 8/3/12).

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FDA gives generics greater importance

Generics/General | Posted 12/10/2012

The Office of Generic Drugs has been promoted to the highest position within FDA because of the great amount of work and income/expenditure now associated with generics.

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Canada takes another step towards generics

Generics/General | Posted 21/09/2012

For the first time, two of Canada’s biggest health insurance companies are going to require that generics be prescribed if one is available.

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Poor quality pharma ingredients abound in China

Generics/General | Posted 14/09/2012

Lack of regulatory enforcement in China is allowing poor quality pharmaceutical ingredients to be sold to drug manufacturers with potentially dangerous or even fatal consequences for patients.

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Austria could save Euros 256 million by using more generics

Generics/General | Posted 07/09/2012

A recent study by IMS Health Austria (IMS) revealed that in Austria healthcare payers could have saved more than a quarter billion Euros during 2011 if physicians would have prescribed more generics to their patients.

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Coupons help Big Pharma to fend off generics

Generics/General | Posted 07/09/2012

Pfizer’s success at using co-pay coupons to prevent patients switching from brand-name products to generics is encouraging other pharmaceutical giants to follow suit.

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Canada grapples with drugs costs

Generics/General | Posted 10/08/2012

Government report calls for the widening of the current scheme for brand-name medicines to include generics.

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UK spending on brand-name drugs predicted to reduce

Generics/General | Posted 06/07/2012

Spending by the UK’s National Health Service (NHS) is under control according to a new report, and in fact spending on brand-name medicines is expected to reduce in real terms and as a proportion of the UK healthcare budget over the next three years.

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Generics have their feet under the table in Malaysia

Generics/General | Posted 06/07/2012

Generics manufacturing, prescribing and sales are becoming firmly part of the scene in Malaysia.

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Generics companies turn to ‘third tier’ countries

Generics/General | Posted 06/07/2012

With pharmaceutical growth in the doldrums in the west, and China and India are becoming increasingly confident, attention is turning to countries such as Indonesia and Turkey.

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Is the pharmaceutical industry on the verge of as big a change as we have seen?

Generics/General | Posted 29/06/2012

‘The old order changeth, yielding place to new’ [1]

For many years the Trade Related Intellectual Property Rights (TRIPS) negotiations have been criticised as being overly protective of the rights of large pharmaceutical companies. ‘It is unacceptable to threaten developing countries aiming to provide medicines to their populations, and disregarding international commitments to ensure access to medicines,’ ran a Médecins sans Frontières statement in 2010. ‘The US is using its trade laws to bully developing countries into applying arbitrary pharmaceutical industry requests at the expense of millions of people who depend on generic medicines in developing countries.’

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Which antiplatelet agent? The debate intensifies

Generics/General | Posted 08/06/2012

Plavix (clopidogrel) has been a blockbuster drug. The lower cost of generic clopidogrel, available for the first time since 17 May 2012 [1], is intensifying debate among cardiologists over how to make sure patients get optimal benefit from any blood-thinning treatment.

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China follows the Indian and Thai route to affordable drugs

Generics/General | Posted 22/06/2012

China announced measures for the Compulsory Licensing for Patent Implementation in a statement on 1 May 2012. The country is saying that it intends to become a generics producer for the domestic and possibly the international market.

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Generics sustainability to be investigated by UK DoH and industry

Generics/General | Posted 25/05/2012

The British Generic Manufacturers Association (BGMA) and the UK Department of Health (DoH) have agreed to work together to investigate potential challenges to the sustainability of the generics industry in the UK.